Progression Free Survival (PFS), the Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease or Death [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: May 1, 2009)

Determine the progression-free survival of patients with stage IIIB/IV NSCLC and an ECOG PS of 2 treated either with first-line pemetrexed, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Time to Progression (TTP), the Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Time to Treatment Failure (TTTF), the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.

Detailed Description

This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Enrollment ICMJE

172

Estimated Completion Date

July 2015

Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Patients must be >=18 years of age.

Non-squamous NSCLC (adenocarcinoma or large cell carcinoma). Mixed tumors with small cell anaplastic elements are not eligible. Mixed tumors with squamous histology are acceptable as long as the squamous element is not the dominant histology.

Patients must have measurable disease per RECIST version 1.1 (see Section 8).

Laboratory values as follows:

Absolute neutrophil count (ANC) ≥1500/μL

Hemoglobin (Hgb) ≥10 g/dL

Platelets ≥100,000/μL (≤7 days prior to treatment)

AST or ALT and alkaline phosphatase (ALP) must be <2.5 x ULN, or <5 x ULN in patients with liver metastases.

Total bilirubin <1.5 x the institutional ULN

Calculated creatinine clearance ≥45 mL/min

The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.

Patient must be accessible for treatment and follow-up.

Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Exclusion Criteria:

Squamous cell histology. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient will be ineligible; sputum cytology alone is unacceptable.

Patients with active brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 2 weeks have elapsed since treatment. Ideally, patients should not still require use of seizure medication or steroids.

Patients who have had major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 4 weeks of beginning treatment; or, the anticipation of the need for major surgical procedure during the course of the study.

Women who are pregnant or lactating.

Minor surgical procedures (with the exception of the placement of portacath or other central venous access) must be completed at least 7 days prior to beginning protocol treatment.

History of hypersensitivity to active or inactive excipients of any component of treatment (pemetrexed, bevacizumab, and/or carboplatin).

Pulmonary carcinoid tumors.

Patients with proteinuria at screening as demonstrated by either:

urine protein creatinine (UPC) ratio ≥1.0 at screening OR

urine dipstick for proteinuria ≥2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection, and must demonstrate ≤1 g of protein/24 hours to be eligible) (see Appendix B)

Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.

Use of any non-approved or investigational agent ≤ 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects